Bioinjection device

ABSTRACT

The bioinjection device has a housing including a pistol grip and an elongated barrel. A trigger is pivotally mounted to the housing. A plunger and needle are slidable between a first position in which the plunger and needle are slidably disposed in the barrel and a second position in which the plunger and needle extend from an opening in the end of the barrel. A retaining member is disposed about the opening at the end of the barrel. A spring-biased actuation mechanism connects the trigger with the plunger and needle. A membranous cartridge containing bone morphogenic protein, antibiotics, and/or other medication is loaded into the retaining member. A surgeon can inject the cartridge into a bone fracture or degenerative bone tissue during surgery to deliver the medicament directly to the affected site.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/458,779, filed Jul. 22, 2009 now U.S. Pat. No. 7,824,359, entitledBIOINJECTION DEVICE, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/129,849, filed Jul. 24, 2008, the contents ofboth of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to devices for the delivery ofpharmaceuticals, and particularly to a bioinjection device fordelivering bone morphogenic protein, antibiotics, etc., directly to thesite of a bone fracture, degenerative bone tissue or cartilage, etc.,during the course of surgery in the form of a bioabsorbable matrixenclosed within a membrane cartridge.

DESCRIPTION OF THE RELATED ART

Bone is a living tissue and plays a structural role in the body. Diseaseand damage, however, is often difficult to treat in bones, due to theirpositioning within the soft tissues of the body. Bone consists ofrepeating Haversian systems (concentric layers of lamellae depositedaround a central canal containing blood vessels and nerves). The centralcanal is also known as the medullary cavity and is filled with bonemarrow. Within the shaft of a long bone, many of these Haversian systemsare bundled together in parallel, forming a type of bone called compactbone, which is optimized to handle compressive and bending forces. Insome bones, such as the metacarpals, for example, the bones themselvesare hollow and contain little, if any, marrow. Near the ends of thebones, where the stresses become more complex, the Haversian systemssplay out and branch to form a meshwork of cancellous or spongy bone.Compact bone and cancellous bone differ in density, or how tightly thetissue is packed together.

Genetic or developmental irregularities, trauma, chronic stress, tumors,and disease can result in pathologies of bones. Some bone diseases thatweaken the bones include, but are not limited to, osteoporosis,achondroplasia, bone cancer, fibrodysplasia ossificans progressiva,fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesisimperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease,and scoliosis. Weakened bones are more susceptible to fracture, andtreatment to prevent bone fractures becomes important. Severe fractures,such as those that are open, multiple, or to the hip or back, aretypically treated in a hospital. Surgery may be necessary when afracture is open, severe, or has resulted in severe injury to thesurrounding tissues. Severe fractures may require internal devices, suchas screws, rods, or plates, to hold the bone in place or replace lostbone during the healing process.

In order to repair severe fractures, bone cement and the like is oftenapplied within the fracture. However, other healing agents, such asantibiotics or bone morphogenic proteins, often need to be applied priorto cementing or performance of other operations on the bone. Due to theawkward positioning of bone fractures within other tissue, it is oftenquite difficult to properly apply medicaments and the like within thebone, particularly without damaging the tissue surrounding the bone.Thus, a bioinjection solving the aforementioned problems is desired.

SUMMARY

The bioinjection device is directed towards a device for injecting orimplanting a membrane-encased cartridge of pharmaceuticals and/orbiologics, bone grafts, radioactive seeds and the like, in abioabsorbable matrix or carrier directly into the site of a bonefracture, degenerative bone tissue or cartilage, or the like in thecourse of surgery. The cartridge may contain bone morphogenic protein,antibiotics, bone, bone substitute or the like.

The device includes a housing having an upper portion and a lowergripping portion. The lower gripping portion may be rotatable withrespect to the upper portion and includes a handle member and a triggermember. The trigger member is pivotally secured to the handle member.Further, the upper portion of the housing has an open interior regionformed therein.

A shaft is slidably mounted within the open interior region of the upperportion of the housing. The shaft has opposed forward and rear ends andis elongated along a longitudinal axis. Further, the shaft has a channelformed therethrough, also extending along the longitudinal axis from theforward end to the rear end.

At least one lever arm is pivotally mounted within the housing, with theat least one lever arm having opposed first and second ends. The firstend of the lever aim is attached to the rear end of the shaft, and thesecond end is attached to the trigger member so that rotation of thetrigger member with respect to the handle member drives slidingtranslation of the shaft with respect to the upper portion of thehousing.

A needle is slidable within the channel formed through the shaft, theneedle having opposed front and rear ends. The front end of the needleterminates in a relatively sharp point. The rear end thereof is attachedto the at least one lever arm so that rotation of the trigger memberwith respect to the handle member drives forward sliding translation ofthe needle with respect to the upper portion of the housing and theshaft. Preferably, the at least one lever arm includes a pair of leverarms, including a first lever arm driving movement of the shaft and asecond lever arm driving movement of the needle.

A retaining member has opposed front and rear ends. The front end isopen and the rear end is attached to a forward portion of the upperportion of the housing. An opening is formed through the rear end of theretaining member and the forward portion of the upper portion so thatthe forward end of the shaft and the front end of the needle selectivelyand slidably project therethrough into an open interior region of theretaining member. The retaining member is preferably releasably attachedto the forward portion of the upper portion of the housing.

A cartridge is releasably received within the open interior region ofthe retaining member. The cartridge includes an outer shell membrane anda medicament contained within the outer shell. The forward end of theshaft contacts the membrane so that actuation of the trigger membercauses the shaft and the needle to slide forward, with the shaft pushingthe cartridge out of the retaining member for deployment thereof intothe bone fracture. As the shaft pushes the implant out of the retainingmember, the needle pierces the outer shell membrane to release themedicament into the fracture or degenerative tissue.

These and other features of the present invention will become readilyapparent upon further review of the following specification anddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an environmental, perspective view of a bioinjection deviceaccording to the present invention;

FIG. 2 is a side view of the bioinjection device according to thepresent invention, broken away and partially in section to show detailsthereof;

FIG. 3 is a perspective view of a membranous cartridge for use with abioinjection device according to the present invention;

FIG. 4 is a partial side view in section of the bioinjection device,showing a cartridge extended from the device for injection orimplantation;

FIG. 5 is a side view of a plurality of removable and fillable heads ofa bioinjection device according to the present invention;

FIG. 6A is a perspective view of an alternative embodiment of thebioinjection device according to the present invention;

FIG. 6B is a perspective view of another alternative embodiment of thebioinjection device according to the present invention;

FIG. 7 is an exploded view of a plurality of alternative bone implantsfor use with the bioinjection device according to the present invention;

FIG. 8 is a front view of a human leg broken away to show the boneimplants of FIG. 7 inserted within a channel formed within a bone;

FIG. 9 is a side view of an alternative embodiment of the head of thebioinjection device according to the present invention; and

FIG. 10 is a side view of another alternative embodiment of thebioinjection device according to the present invention.

Similar reference characters denote corresponding features consistentlythroughout the attached drawings.

DETAILED DESCRIPTION

The present invention relates to a bioinjection device 10. As shown inFIG. 1, device 10 is used to place a cartridge 12 into a fracture,degenerative tissue, or the like of a spinal segment S. The cartridge 12contains a medicament (bone morphologic protein, antibiotics, or thelike disposed in a bioabsorbable matrix or carrier) for the healing ofthe spinal segment S. It should be understood that spinal segment S,having vertebral bodies V, disc D and facet joint F, of FIG. 1 is shownfor exemplary purposes only and is not intended to limit the type ofbone or fracture that the cartridge 12 and device 10 may be used totreat.

As best shown in FIGS. 1 and 2, the device 10 includes a housing 32having a barrel-shaped upper portion 33 and a lower gripping portion 35.The lower gripping portion 35 may be rotatable with respect to the upperportion 33 and includes a pistol grip handle member 34 and a triggermember 36. The trigger member 36 is pivotally secured to the handlemember 34 by a pivot pin 39 or the like. Trigger member 36 preferablyhas a plurality of finger receiving grooves or recesses 38 formedtherein, as shown in FIG. 2, allowing for optimal gripping and actuationby the surgeon. Further, an upper gripping handle 11 may be mounted onan upper surface of housing 32, allowing the surgeon to better grip andsecure tool 10 during the surgical operation.

As noted above, the lower portion 35, including both handle member 34and trigger member 36, may be rotatable about pivot 37, allowing thelower gripping portion 35 to be rotated if necessary, depending upon thenature of the particular operation. The lower portion 35 may further beselectively locked in place with respect to the upper portion 33.Further, as shown in FIG. 2, the barrel-shaped upper portion 33 ofhousing 32 has an open interior region formed therein.

As shown in FIG. 2, a shaft 16 is slidably mounted within the openinterior region of the upper portion 33 of the housing 32. The shaft hasopposed forward and rear ends 21, 22, respectively, and is elongatedalong a longitudinal axis, as shown. Further, the shaft 16 has alongitudinally extending channel 25 formed therethrough, extending fromthe forward end 21 to the rear end 22. Shaft 16 is preferablyresiliently or spring-biased with respect to housing 32. In thepreferred embodiment, a stop 13, such as a disc, is mounted to a centralportion of shaft 16, as shown in FIG. 2, with a spring 20 or otherresilient element being biased between the stop 13 and the inner wall offorward portion 50 of housing 32.

At least one lever arm is pivotally mounted within housing 32 for theactuation of shaft 16. Preferably, the at least one lever arm includes apair of lever aims with a first lever arm 28 driving movement of theshaft 16, and a second lever arm 26 driving movement of needle 18, aswill be described in greater detail below. First lever arm 28 hasopposed first and second ends, with the first end of first lever arm 28being secured to the rear end 22 of shaft 16, and the second end beingsecured to the trigger member 36 so that rotation of the trigger member36 with respect to the handle member 34 drives sliding translation ofthe shaft 16 with respect to the upper portion 33 of the housing 32.

Needle 18 is slidably received within the channel 25 formed through theshaft 16, with the needle 18 having opposed front and rear ends 27, 29,respectively (the front end or tip 27 of needle 18 is best shown in FIG.4). The front end 27 of needle 18 is preferably formed as a relativelysharp point. The rear end 29 of needle 18 is secured at 24 to the secondlever arm 26 so that rotation of trigger member 36 with respect to thehandle member 34 drives forward sliding translation of the needle 18with respect to the upper portion 33 of the housing 32 and also withrespect to the shaft 16; i.e., actuation of trigger member 36 causesforward sliding of shaft 16 within the housing 32 and also forwardsliding of needle 18 within the shaft 16.

A retaining member 14 is further provided, with the retaining memberhaving opposed front and rear ends. As shown, retaining member 14preferably forms a pair of gripping jaws for releasably holding implant12. The front end thereof is open and the rear end thereof is secured tomounting member 52, which is fixed to a forward portion 50 of the upperportion 33 of the housing 32. The rear portion of retaining member 14 ispreferably releasably attached to the mounting member 52 through use ofany suitable releasable fastener. The rear portion may have threads 58formed thereon, as best shown in FIG. 4, for reception by a threadedrecess 53 formed in mounting member 52.

Further, an opening 19 is formed through the rear end of the retainingmember 14, and a passage 17 is formed through the forward portion 50 ofhousing 32 so that the forward end 21 of shaft 16 and the front end 27of the needle 18 selectively and slidably project therethrough into anopen interior region of the retaining member 14.

Cartridge 12 is releasably received within the open interior region ofthe retaining member 14. As best shown in FIG. 3, the cartridge 12includes an outer shell membrane 40 and a medicament 42 contained withinthe outer shell 40. The medicament 42 may be a bone morphogenic protein,an antibiotic, or any other desired medicament for the healing of thebone, and may be disposed in a bioabsorbable matrix or carrier. Theouter shell may be formed from hydroxyapatite calcium phosphate, or anyother biodegradable material that will dissolve and/or fuse within thebone. Preferably, the rear end 46 of shell 40 is formed as a relativelythin membrane that can be pierced by tip 27 of needle 18. A further thinmembrane 44 may be formed between the outer shell 40 and the medicament42.

In use, the cartridge 12 is positioned within retaining member 14, asshown in FIG. 2, with the forward end 21 of shaft 16 contacting the rearsurface 46 of the bone implant 12. Actuation of trigger member 36 causesthe shaft 16 and the needle 18 to slide forward. Retaining member 14 ispreferably formed from a flexible material, such as rubber, plastic orthe like, so that forward movement of shaft 16 pushes the cartridge 12out of the open front end of the retaining member 14 for deploymentthereof into the bone fracture or other damaged or diseased area. As theshaft 16 pushes the cartridge 12 out of the retaining member 14, the tip27 of needle 18 pierces the thin membrane 46 to release the medicament42 into the fracture. The surgeon lodges the pierced cartridge 12 withinfracture F or the degenerative bone tissue.

In FIG. 9, retaining member or head 14 of FIG. 4 has been replaced by analternative head 214, having a rear portion 216 with threads 258,similar to threaded connection 58 of FIG. 4. A pair of spring-biasedjaws 218 are mounted to the rear portion 216, with one or both of thejaws 218 being adapted for releasably gripping a bone dowel 220 or thelike for insertion into a facet joint FJ. In the embodiments of FIGS. 2and 9, the heads 14, 214 and the shaft have relatively small sizes,allowing for placement within the facet joint, as noted above. However,it should be understood that the head and/or shaft may have any suitablesize, dependent upon the site for placement of the cartridge. As will bedescribed in detail below, a longer shaft and head may be necessary forinjection of cartridges within a larger or longer bone, such as a tibia,and the shaft and head may be appropriately sized dependent upon theintended injection site.

FIG. 6A illustrates an alternative embodiment of the bioinjectiondevice. Bioinjection device 100 includes a housing 132 having upper andlower portions 133, 135, similar to that of the embodiment of FIGS. 1-4.Similarly, the lower portion 135 includes a handle member 134 and atrigger member 136, and the upper portion 133 has a handle 111 mountedthereon. Side handles 115 may also be mounted to upper portion 133, asshown, offering the surgeon a variety of gripping surfaces for differingangles of insertion during an operation. In the embodiment of FIG. 6A,an elongated tube 114 is mounted to the front end of barrel-shaped upperportion 133, allowing for the implanting of bone implants whereimmediate proximity of the surgeon's hands is not possible, such as inthe implantation of implants 112 within channel C formed in tibia T ofFIG. 8.

The elongated tube 114 includes an adjustable portion 126, allowing forangular adjustment of the tube 114 adjacent the front end of the upperportion 133 of housing 132. Adjustable portion may be a rotating andselectively locking disc member, as shown, or may be any other suitableangular adjustment device. A central region 128, preferably being solidand relatively non-flexible, is joined to the flexible portions 126 atone end thereof, and a head 120 is disposed at the other end of tube114. Head 120 has an open outer end with external threads 124 formedtherearound.

The retaining jaws 14 of the embodiment of FIGS. 1-5 are replaced inFIG. 6A by a cylindrical retaining member 130 having opposed open ends.Retaining member 130 is formed from a resilient, flexible material,similar to that described above with regard to jaws 14. Internal threads140 are formed in one end of the retaining member 130 for releasableattachment to the head 120 via engagement with threads 124. It should beunderstood that retaining member 130 may be releasably secured to head120 through any suitable releasable fastener.

An implant 112 is received within retaining member 130 for selectivedispensing thereof. Similar to that described above with regard to theembodiment of FIGS. 1-5, an inner shaft 116, similar to shaft 16,extends through tube 114 and is shown in FIG. 6A slightly projectingfrom head 120. Shaft 116 preferably has a plunger-type shape, as shown,with a relatively wide outer face for pushing the wider implant 112. Aneedle 118, similar to needle 18, is housed within shaft 116. Thealternative embodiment of FIG. 6B is substantially similar to that shownin FIG. 6A, but shaft 116 terminates in a covering head 117, whichcovers and surrounds the needle 118 and prevents the needle 118 frombecoming caught in the implant 112. In operation, the user actuatestrigger 136 to slide the shaft 116 and needle 118 forward so that theshaft 116 pushes the implant 112 out of retaining member 130 and needle118 pierces the implant 112, as described above. When retaining member130 is fixed to head 120, the head of plunger 116 will project out fromretaining member 130 (when the trigger is compressed) by approximatelyone or two mm.

Implant 112 is preferably formed from materials similar to thosedescribed above with reference to implant 12. However, as best shown inFIG. 7, implant 112 preferably includes an upper projecting member 113and a lower recess 119. As shown in FIG. 7, multiple implants 112 may bestacked through insertion of an upper projecting member 113 into thelower recess 119 of an adjacent implant.

As shown in FIG. 5, the removable retaining members 130 may be storedand filled within a tray 54. In order to allow for quick insertion andreplacement of cartridges 112, cartridges 112 may be positioned withinretaining members 130, as shown. Tray 54 preferably includes a pluralityof channels 56 for filling of cartridges 112 within the stored retainingmembers 130. A syringe 62 or other supply of medicament may be appliedto ports 60, which cover and seal channels 56, allowing the medicamentto be transferred to the cartridges 112. Communication with, and fillingof, cartridges 112 may be accomplished through any suitable fluidtransfer mechanism.

FIG. 8 illustrates this stacked implantation within a channel C formedwithin an exemplary tibia T. Such channels C are often formed from thetalus to the knee during the implantation of rods and the like in tibialreconstruction. The device 100 of FIG. 6 allows for easy insertion ofmultiple implants 112 within channel C after removal of such a rod.

In the alternative embodiment of FIG. 10, device 200 allows for manualinsertion and operation of the implant 112. A gripping handle portion204 is secured to a lower surface of mount 202. Hollow insertion tube206 is mounted on a front portion of the upper surface of mount 202, asshown. The rear portion of the upper surface of mount 202 may have agroove, ridge or other means for slidably holding implant 112. A plunger208 is provided, with plunger 208 having a gripping, rear portion and afront portion terminating in a plunger head 210, with needle 212 beingpositioned centrally therein. In operation, the user loads an implant112 onto the rear, upper surface of mount 202, as shown, and pushesimplant 112 through tube 206, for insertion, with plunger head 210pushing implant through tube 206 and needle 212 piercing the rear end ofimplant 112, as described above.

1. A bioinjection device, comprising: a housing having a pistol grip andan elongated barrel mounted on the pistol grip, the barrel having afront end defining an opening; a trigger pivotally mounted on thehousing; an elongated plunger having a channel formed therethrough, anda pointed needle received within the channel and extending therefrom,the plunger being slidable between a first position in which the plungerand pointed needle are retracted within the barrel and a second positionin which the plunger and pointed needle extend through the opening atthe front end of the barrel; a retaining member disposed about theopening at the front end of the barrel, the retaining member beingadapted for loading a membranous cartridge containing a bone healingmedicament therein; and a spring-loaded actuation mechanism coupling thetrigger with the plunger and the pointed needle in order to eject themembranous cartridge from the retaining member into bone tissue andpierce an outer membrane of the membranous cartridge to release themedicament into the bone tissue during surgery when the trigger issqueezed.